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Regulations

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12Jul 2024
EU, Regulations Cubicdesignz

Annex XVI – EU MDR

What is an Annex XVI product? Annex XVI products are those for which a manufacturer claims only an aesthetic or another non-medical purpose but are like medical devices in terms of functioning and risk profile. These categories of products were added in the new Regulation to establish production and surveillance standards for these previously unregulated products to protect users’ health and safety. LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) When...
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12Jul 2024
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Regulatory Pathway for Clinical Investigation in the EU

Regulatory Pathway for Clinical investigation creates a set of clinical data that is crucial to understanding the effectiveness of a medical device. Clinical Investigation is done for previously CE marked devices or for research medical devices. Clinical Investigation is governed by a clinical investigation plan with an objective, methodology, and record keeping. Top 5 Steps involved in Clinical Investigation Step 1 Appointment of a Representative- Appoint a legal representative....
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12Jul 2024
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LEGACY MEDICAL DEVICES REQUIREMENTS IN EUROPE

Legacy medical devices include all previously regulated devices under the Medical Devices Directives (MDD 93/42/EEC 90/385/EEC) and In-vitro Diagnostic Devices Directive (IVDD 98/79/EC). Medical Device Coordination Group (MDCG) published the guidance documents on the Application of EU MDR to legacy devices and Legacy device management for Legacy devices. There are three terminologies to guide the manufacturers – old devices, legacy devices and MDR devices. ‘Old devices’...
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12Jul 2024
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ISO 20417:2021 – Information to be supplied by the Manufacturer

Engineered medical devices are introduced to the market for use in clinical scenarios. From a user’s perspective, the safe and effective usage of a medical device is highly influenced by providing appropriate accompanying information with the device labels and user instructions. An international standard that defines the information to be supplied by the manufacturer of Medical Devices is ISO 20417:2021, with the latest version as ISO 20417:2021. Besides, ISO 15223 stands for requirements that...
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12Jul 2024
EU, Regulations admin

Quality Management System Requirements of EU MDR

Quality Management Systems (QMS) are defined by the MDR as formalised systems that document processes, responsibilities, and procedures to ensure and continually improve the standard of company activities. To obtain CE marking and market devices in European Union, an effective Quality Management System that complies with EU MDR 2017/745 is must. Article 10 of EU MDR 2017/745 explains the general obligation of manufacturers to place their products in the EU market. A...
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12Jul 2024
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Implant Cards for Europe

The European Union’s Medical Device Regulation (MDR 2017/745) introduces a new requirement for manufacturers producing implant cards for medical devices. As per EU MDR, implantable devices are any devices, other than the active implantable devices, that are partially or completely implanted into the human body or are used to replace an epithelial surface or the surface of the eye, by clinical intervention, and are meant to stay in place after the procedure. The device that is intended to be pa...
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12Jul 2024
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Importance of Human Translations vs Machine Translations

Human translation Human translations produce accurate results because it involves at least one language expert. Translations, with a human touch to them, are precise because of the in-depth knowledge that translators carry Human translations are done by native speakers of a particular language or people certified in language translations . Therefore, it is culturally diverse, nuanced and is of high quality. However, this high-quality product is expensive. Machine translation Machine transla...
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12Jul 2024
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UDI DI

UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally introduced the UDI system in the EU. The UDI comprises the following components The Basic UDI-DI is a technique introduced by the EU for linking medical devices to their regulatory documentation so that the model of the product can be uniquely identified throughout its entire lifecycle. The linked documentation may include the declaration of conformity, notified body certificates,...
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12Jul 2024
EU, Regulations admin

EU MDR – Article 117

EU MDR – Article 117 – The French Poly Implant Prostheses (PIP) breast implant controversy prompted medical rules to be revised and formed new Medical Devices and In-Vitro Devices Regulations to safeguard public health. As per the European Medicines Agency (EMA) definition, a medicinal device is a substance or combination of substances intended to treat, prevent or diagnose a disease, or restore, correct or modify physiological functions by exerting a pharmacological immunological...
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12Jul 2024
EU, General Information, Regulations Cubicdesignz

Smart Wearables Regulations in the EU 

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation. Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place. How are these general we...
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